FDA’s Updates Guidances, Still Urges Against Hand Sanitizer with Methanol

August 12th, 2020 by Editor

The Federal Drug Administration (FDA) issued updated its guidances to provide additional clarification for testing the alcohol used in hand sanitizers manufactured under FDA’s temporary policies, to help ensure that harmful levels of methanol are not present in these products and ensure widespread access to alcohol-based hand sanitizers that are free of contamination.

The updates provide clarification that companies test each lot of the active ingredients, either ethanol or isopropyl alcohol (IPA), for methanol if either is obtained from another source. An ethanol or IPA with more than 630 ppm methanol may be considered contaminated and subject to adulteration charges under the FD&C Act. The ethanol or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.

For more information, CLICK HERE.

Tags: , , , , ,

Leave Comment